SmokingNCT02649556

A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2

A study testing THS 2.2 and CC in people with Smoking, run by Philip Morris Products S.A. at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: THS 2.2 and CC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 672 participants
Where: 19 sitesUnited States
Study dates: 30 Sep 2015to 20 Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject completed V10 of the original study (ZRHR-ERS-09-US).
The subject is willing to comply to study procedures and to continue to use the product he/she was allocated to during the original study (THS 2.2 or CC) for an additional 26 weeks at V10.
Subject has given written informed consent to enter the 26-week extension study at V10.

Who cannot join

Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
As per judgment of the PI(s) or designee(s), the subject cannot participate in the study for any reason (e.g. medical, psychiatric and/or social reason).
Subject has made an attempt to quit using tobacco-containing products (e.g. CC and THS 2.2) during the original study.
Female subject is pregnant or breast feeding.
Female subject who does not agree to use an acceptable method of effective contraception.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Benchmark
Austin, Texas, 78705
PMG Research of Bristol
Bristol, Tennessee, 37620
PMG Research of Cary
Cary, North Carolina, 27518
PMG Research of Charlotte
Charlotte, North Carolina, 28209
Clinical Research West Florida
Clearwater, Florida, 33765
Midwest Clinical Research
Dayton, Ohio, 45417
Covance, Inc
Daytona Beach, Florida, 32117
Benchmark
Fort Worth, Texas, 76135
NOCCR
Knoxville, Tennessee, 37920
Central Kentucky Research Associate
Lexington, Kentucky, 40509
Celerion Lincoln
Lincoln, Nebraska, 68502
Compass Research
Orlando, Florida, 32806
PMG Research of Raleigh
Raleigh, North Carolina, 27609
National Clinical Research
Richmond, Virginia, 23294
Benchmark
San Angelo, Texas, 76904
Clinical Research West Florida
Tampa, Florida, 33603
Celerion Arizona
Tempe, Arizona, 85283
Compass Research
The Villages, Florida, 32162
PMG Research of Wilmington
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A 26-week Extension Study to Determine the Biological and Functional Changes in Healthy Smokers Who Switched From Conventional Cigarettes (CC) to Tobacco Heating System 2.2 (THS 2.2) Compared to Those Who Continued to Smoke CC in the ZRHR-ERS-09-US Study

The objective of the ZRHR-ERS-09-EXT-US study is to further assess the effect of the Tobacco Heating System 2.2 (THS 2.2), a candidate Modified Risk Tobacco Product, compared to conventional cigarettes (CC) on the components of the "smokers' health profile" for a prolonged period of 26 weeks, providing additional information to the results of the original study ZRHR-ERS-09-US of 26-week exposure (NCT02396381). In total, the ZRHR-ERS-09-EXT-US study will extend the exposure period to 52 weeks.

Read the detailed description

The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US.

The subjects in the Full Analysis Set - As Exposed (FAS-EX) included subjects for combined analyses from the original six month study (ZRHR-ERS-09-US ) who did not enter the extension study (ZRHR-ERS-09-EXT-US).

This study was conducted as a separate investigation, as a follow-up of the randomized exposure period of the original study, extending the exposure from Week 26 (Visit 10 [V10]) to Week 52 (Visit 16 [V16]), and using the same sites.

Subjects continued to use the product they were randomized to in the original study ZRHR-ERS-09-US (THS 2.2 arm or CC arm).

Conditions: Smoking
Being tested: THS 2.2, CC
Keywords: Modified risk tobacco product, Conventional cigarette, Exposure response, Smoking, Tobacco Heating System
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

THS 2.2Other
Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks.
CCOther
Ad libitum use of CC in an ambulatory setting for 26 weeks.
The subject's own preferred brands of CC (no brand restriction) continue to be used as the reference product.

Study groups in NCT02649556
Study group	Role	What they receive
THS 2.2	Experimental	Ad libitum use of THS 2.2 Receives: Other: THS 2.2
CC	Active comparator	Ad libitum use of CC Receives: Other: CC

What is being measured

The primary outcome is the main question the study is designed to answer.

Levels of High Density Lipoprotein C (HDL-C).
Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.
Measured: 52 weeks
Levels of White Blood Cells (WBC).
Total count in blood (GI/L). Mean values are provided as descriptive statistics.
Measured: 52 weeks
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).
FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.
Measured: 52 weeks
Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.
Measured: 52 weeks
Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).
Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Measured: 52 weeks
Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).
Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Measured: 52 weeks
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).
Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Measured: 52 weeks
Levels of Carboxyhemoglobin (COHb).
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Mean values are provided as descriptive statistics.
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 201520 Dec 2017

First posted7 Jan 2016 (estimated)
Study start30 Sep 2015
Primary completion13 Mar 2017
Study completion20 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 672 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02649556
Sponsor's protocol ID: ZRHR-ERS-09-EXT-US
Other IDs: ZRHR-ERS-09-EXT-US
Status last verified: Nov 2020
First submitted: 5 Jan 2016
Last updated: 4 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ansari SM, Hession PS, David M, Blanc N, de La Bourdonnaye G, Pouly S, Haziza C. Impact of switching from cigarette smoking to tobacco heating system use on biomarkers of potential harm in a randomized trial. Biomarkers. 2024 Jul;29(5):298-314. doi: 10.1080/1354750X.2024.2358318. Epub 2024 Jun 7.
PubMed 38804903

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 26-week Extension Study to Determine the Biological and Functional Changes in Healthy Smokers Who Switched From Conventional Cigarettes (CC) to Tobacco Heating System 2.2 (THS 2.2) Compared to Those Who Continued to Smoke CC in the ZRHR-ERS-09-US Study
ClinicalTrials.gov ID: NCT02649556
Acronym / sponsor ID: ZRHR-ERS-09-EXT-US
Conditions: Smoking
Keywords: Modified risk tobacco product, Conventional cigarette, Exposure response, Smoking, Tobacco Heating System
Study type: Interventional
Recruitment status: Completed
Enrolment: 672 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: 30 Sep 2015 (actual)
Primary completion: 13 Mar 2017 (actual)
Study completion: 20 Dec 2017 (actual)
First posted: 7 Jan 2016 (estimated)
Results: Posted 4 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US.

Subjects continued to use the product they were randomized to in the original study ZRHR-ERS-09-US (THS 2.2 arm or CC arm).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
THS 2.2	Experimental	Other: THS 2.2Ad libitum use of THS 2.2
CC	Active comparator	Other: CCAd libitum use of CC

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject completed V10 of the original study (ZRHR-ERS-09-US).
The subject is willing to comply to study procedures and to continue to use the product he/she was allocated to during the original study (THS 2.2 or CC) for an additional 26 weeks at V10.
Subject has given written informed consent to enter the 26-week extension study at V10.

Key exclusion criteria (5 listed)

Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
As per judgment of the PI(s) or designee(s), the subject cannot participate in the study for any reason (e.g. medical, psychiatric and/or social reason).
Subject has made an attempt to quit using tobacco-containing products (e.g. CC and THS 2.2) during the original study.
Female subject is pregnant or breast feeding.
Female subject who does not agree to use an acceptable method of effective contraception.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
THS 2.2Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks.	Other	THS 2.2
CCAd libitum use of CC in an ambulatory setting for 26 weeks. The subject's own preferred brands of CC (no brand restriction) continue to be used as the reference product.	Other	CC

Primary outcome

Levels of High Density Lipoprotein C (HDL-C).
Time frame: 52 weeks
Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.
Levels of White Blood Cells (WBC).
Time frame: 52 weeks
Total count in blood (GI/L). Mean values are provided as descriptive statistics.
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).
Time frame: 52 weeks
FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.
Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
Time frame: 52 weeks
Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.
Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).
Time frame: 52 weeks
Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).
Time frame: 52 weeks
Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).
Time frame: 52 weeks
Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Levels of Carboxyhemoglobin (COHb).
Time frame: 52 weeks
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Mean values are provided as descriptive statistics.

Results and safety

Results posted to the registry on 4 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
THS 2.2 Use	230	167
CC Use	424	312
Dual Use	152	102
Other Use	51	28

Primary outcome: Levels of High Density Lipoprotein C (HDL-C).

Time frame: 52 weeks. Mean (95% Confidence Interval). Unit: mg/dL

Measure	THS 2.2 Use n = 168	CC Use n = 315	Dual Use n = 103	Other Use n = 28
Value	52.2 (49.5 to 54.8)	50.6 (48.9 to 52.3)	54.0 (49.7 to 58.4)	54.7 (49.2 to 60.3)

THS 2.2 Use vs CC Use: LS Mean Difference: 1.75 (95% CI -0.160 to 3.65)

Population analysed: Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Primary outcome: Levels of White Blood Cells (WBC).

Time frame: 52 weeks. Mean (95% Confidence Interval). Unit: GI/L

Measure	THS 2.2 Use n = 167	CC Use n = 312	Dual Use n = 102	Other Use n = 28
Value	6.73 (6.47 to 6.99)	7.31 (7.07 to 7.54)	7.28 (6.85 to 7.71)	7.57 (6.85 to 8.29)

THS 2.2 Use vs CC Use: LS Mean Difference: -0.413 (95% CI -0.694 to -0.131)

Population analysed: Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Primary outcome: Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).

Time frame: 52 weeks. Mean (95% Confidence Interval). Unit: Percent of predicted FEV1

Measure	THS 2.2 Use n = 153	CC Use n = 288	Dual Use n = 95	Other Use n = 27
Value	93.2 (91.1 to 95.2)	92.3 (90.7 to 94.0)	91.1 (88.2 to 94.1)	95.2 (90.1 to 100)

THS 2.2 Use vs CC Use: LS Mean Difference: 0.914 (95% CI -0.339 to 2.17)

Population analysed: Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Primary outcome: Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).

Time frame: 52 weeks. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	THS 2.2 Use n = 168	CC Use n = 315	Dual Use n = 103	Other Use n = 28
Value	246 (230 to 263)	258 (244 to 272)	269 (252 to 286)	255 (222 to 292)

THS 2.2 Use vs CC Use: % Relative Reduction: 3.11 (95% CI 0.0231 to 6.10)

Population analysed: Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Adverse events

Time frame: 18 months (from March 2015 to September 2016). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
THS 2.2 Use	12 of 241 (5%)	40 of 241 (16.6%)	1 of 241
CC Use	15 of 434 (3.5%)	87 of 434 (20%)	1 of 434
Dual Use	1 of 159 (0.6%)	26 of 159 (16.4%)	0 of 159
Other Use	1 of 106 (0.9%)	13 of 106 (12.3%)	1 of 106

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38804903Ansari SM, Hession PS, David M, Blanc N, de La Bourdonnaye G, Pouly S, Haziza C. Impact of switching from cigarette smoking to tobacco heating system use on biomarkers of potential harm in a randomized trial. Biomarkers. 2024 Jul;29(5):298-314. doi: 10.1080/1354750X.2024.2358318. Epub 2024 Jun 7.
Individual participant dataSharing planned: No

Related trials for Smoking

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christelle Haziza, PhD study chair

Philip Morris Products S.A.

Danielle Armas, MD principal investigator

Celerion Arizona

Leonard Dunn, MD principal investigator

Clinical Research West Florida

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing THS 2.2 and CC in people with Smoking, run by Philip Morris Products S.A. at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of High Density Lipoprotein C (HDL-C). (time frame: 52 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02649556, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.